Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[pib] Amendment to the Export Policy of APIs and formulations made from these APIs


From UPSC perspective, the following things are important :

Prelims level: Active Pharmaceutical Ingredients

Mains level: Regulations of API

The Government has made amendments in the export policy and restricted export of specified APIs (Active Pharmaceutical Ingredients) and formulations made from these APIs.

Active Pharmaceutical Ingredients (APIs)

  • All drugs are made up of two core components: the API, which is the central ingredient, and the excipients, the substances other than the drug that helps deliver the medication to your system.
  • The API is the part of any drug that produces its effects.
  • Excipients are chemically inactive substances, such as lactose or mineral oil.
  • The quality of APIs has a significant effect on the efficacy and safety of medications.

The notification covers the following APIs and formulations made from these APIs:

  • Paracetamol
  • Tinidazole
  • Metronidazole
  • Acyclovir
  • Vitamin B1
  • Vitamin B6
  • Vitamin B12
  • Progesterone
  • Chloramphenicol
  • Erythromycin Salts
  • Neomycin
  • Clindamycin Salts
  • Ornidazole

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